CLASS II Device recall · Reported 19 Dec 2012 · FDA Enforcement Report
LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer recalled
Roche Molecular Systems is recalling LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with, distributed nationwide in the US. The recall was initiated on 16 Jul 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0487-2013
- FDA event ID
- 63312
- Recalling firm
- Roche Molecular Systems, Branchburg, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jul 2012
- FDA classified
- 7 Dec 2012
- Reported
- 19 Dec 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 16 Jul 2012 | Recall initiated by company | |
| 7 Dec 2012 | Classified by FDA | +144 days |
| 19 Dec 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis with corresponding assays.
Where it was distributed
Nationwide Distribution
Stores named: Target
Questions about this recall
Is LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with recalled?
Yes. Roche Molecular Systems recalled LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with on 16 Jul 2012. The recall is Class II and its status is Terminated. Recall number Z-0487-2013.
Why was it recalled?
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Which lots are affected?
Device-associated diagnostic software
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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